The devices are not intended to replace other means of evaluating vital patient physiological processes, are not intended to be used in fetal applications, and are not intended to be used inside the sterile field.

They are to be used by trained medical personnel in hospitals, clinics and physicians offices by prescription or doctor's orders.

Device Description

The Falcon/Pro, Falcon/Quad, and Falcon/ABI+ systems are part of the Falcon product family of non-invasive peripheral vascular diagnostic systems. The Falcon/Pro is a complete peripheral vascular system that supports 10 independent pressure channels, 5 PPG sensors, 3 Doppler frequencies, and a temperature sensor. The Falcon/Quad and the Falcon/ABI+ systems are merely sub-assemblies of the Falcon/Pro system. Both support only 4 pressure channels, 4 PPG sensors and a temperature sensor. The Falcon/Quad also includes support for the 3 Doppler frequencies, while the Falcon/ABI+ does not support any Doppler features.

The Falcon/Pro and its' sub-assemblies Falcon/Quad and Falcon/ABI+ share the same hardware and software. While the main printed circuit board (PCB) is identical, the pneumatic components such as pumps, valves, sensors and check valves are assembled in the Falcon/Quad and Falcon/ABI+ to support only 4 pressure channels. In addition, one PPG sensor is omitted from the assembly of these systems. Furthermore, the Doppler board with its' PCB mount probe connectors is not assembled in the Falcon/ABI+ system. The same metal enclosure and connectors are used for the Falcon/Pro. Falcon/Quad, and Falcon/ABI+. The only difference lies in the front panel which is adapted according to the number of PPG sensors and Doppler probes.

The software level of concern for the Falcon products is determined as Moderate. The software of the Falcon/Pro, Falcon/Quad, and Falcon/ABI+ systems is practically identical. The only software differences are as follows: the Falcon/Pro supports 10 pressure cuffs (tubing marked in red, blue, green, yellow, orange, and white with lines in red. blue, green, yellow, and orange), while the sub-assemblies support only 4 pressure cuffs (tubing marked in red, blue, green, yellow); the Falcon/Pro supports 5 color coded PPG sensors (red, blue, green, vellow and black) while the sub-assemblies support only 4 such sensors (red, blue, green, yellow); the default examination protocols are adapted according to the supported sensors and probes; the maximal protocol group allowed with the Falcon/Pro is 10. while the maximal allowed group for the sub-assemblies is 9: and the Falcon/ABI+ does not support any of the Doppler options and features.

All other software features are identical for the Falcon/Pro and the 2 sub-assemblies Falcon/Quad and Falcon/ABI+. Some of the main features include patient details and patient database management; Dicom connectivity; printing configuration and printing options; writing examination reports; summary screen support; configuration and management of examination protocols: measurement site configuration: export in various formats: import of VSX files; backup features; restoring backup data: online help options: and review stations. All of the standard signal control options and signal display options. as well as measurement calculations, are identical for all 3 systems (excluding Doppler related options for the Falcon/ABI+ system).

The quantitative measurements are the same for Falcon/Pro and the 2 sub-assemblies Falcon/Quad and Falcon/ABI+. The main measurement of the 3 systems is segmental systolic blood pressures. In general, the measurement is conducted by applying an appropriately sized cuff to the measured segment, obtaining a reference PPG or a Doppler signal in a location distal to the cuff placement, and then inflating the cuff to such a pressure that will occlude the blood vessels and prevent blood flow distal to the cuff location, which will result in disappearance of the reference signal. Then, a slow cuff deflation begins, and the instantaneous cuff pressure at which the reference signal reappears is typically defined as the segmental systolic blood pressure. While the software automatically places a cursor at the time location which is suspected as being the systolic pressure, it is the total responsibility of the system operator and the medical staff to modify the cursor location according to their medical training, and define the correct segmental pressure.

Based on the segmental pressures, the pressure indices are calculated, as the ratio between the systolic segmental pressure, and the higher of the 2 brachial systolic pressures. The ABI index is a commonly used index, which is a specific case of the above, calculated as the systolic right or left ankle pressure, divided by the higher of the right or left brachial systolic pressure.

The standard main Doppler parameters that are calculated (not for the Falcon/ABI+ system), include: Mean, representing the time-average value of the envelope (maximal velocity/frequency) over one cardiac cycle; Peak, representing the maximal systolic velocity/frequency during a cardiac cycle, in units of cm/sec or KHz; Diast, representing the minimal diastolic velocity/frequency during a cardiac cycle, in units of cm/sec or KHz; PI, representing the Gosling Pulsatility Index, calculated based on the peak envelope as (peak systolic velocity - minimal diastolic velocity) / mean velocity; RI. representing the Pourcelot Resistance Index. calculated based on the peak envelope as (peak systolic velocity - minimal diastolic velocity) / peak systolic velocity; S/D. representing the systolic to diastolic flow ratio, and is calculated based on the peak envelope as: (peak systolic velocity / minimal diastolic velocity); and HR, representing heart rate in beats (number of cardiac cycles) per minute.

Additional parameters that are displayed are related to the specialty tests. During stress testing, a digital timer indicates the duration of the exposure to stress (for example the total time the patient exercised), and the recovery time for each measurement (the time that passed since the end of stress exercise and the current measurement). During venous reflux testing the system automatically places vertical cursors that denote the minimal PPG signal after sequential leg dorsiflexions and the point in time that the PPG signal returns to pre-dorsiflexion baseline. The time difference between these 2 cursors is calculated and referenced as the VRT (venous refill time). It is the responsibility of the examiner to determine the correct vertical cursor position, hence adjusting the VRT parameter. Likewise, the MVO/SVC ratio is based on the horizontal baseline and plateau signals, and the rate of signal drop immediately after rapid deflation of the thigh cuff. Again, it is the responsibility of the examiner to determine the correct cursor positions for the parameter calculation.

The Falcon complies with Class B EMC requirements. Therefore, the Falcon is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

AI/ML Overview

The provided text describes the Falcon/Pro, Falcon/Quad, and Falcon/ABI+ systems, which are non-invasive peripheral vascular diagnostic systems. However, it does not contain information about specific acceptance criteria or a study proving that the device meets those criteria with statistical measures of performance like accuracy, sensitivity, or specificity. Instead, it focuses on demonstrating substantial equivalence to predicate devices.

The document indicates that the devices have undergone "extensive safety, performance testing, and validation" and that "various performance testing" was conducted to ensure they meet their functional specifications. It also mentions compliance with several international safety and electrical standards (EN 60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62304, ISO 14971).

Since explicit acceptance criteria and corresponding performance data are not provided, the following table and subsequent sections highlight what is mentioned and what is missing.

Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion	Reported Device Performance	Comments
Functional Specifications Compliance	"devices meet all of their functional specifications"	Broad statement without specific metrics or evidence.
Safety Standards (EN 60601-1, IEC 60601-2-37, ISO 14971)	"certified by an approved laboratory" to comply with standards	Implies regulatory compliance rather than specific performance metrics for the diagnostic output.
EMC Standards (IEC 60601-1-2)	"certified by an approved laboratory" to comply with standards; "complies with Class B EMC requirements"	Confirms electromagnetic compatibility.
Software Life Cycle (IEC 62304)	"certified by an approved laboratory" to comply	Confirms software development process adherence.
Specific Diagnostic Performance Metrics (e.g., accuracy, sensitivity, specificity, agreement with a gold standard for ABI measurements, Doppler velocity, VRT, MVO/SVC ratio)	NOT PROVIDED IN THE SUBMISSION	This is the key missing information for clinical acceptance criteria.

Detailed Breakdown of Missing Information as Per Request:

A table of acceptance criteria and the reported device performance:
- As shown above, the document largely refers to compliance with safety and functional specifications broadly. There are no explicit, quantifiable acceptance criteria related to diagnostic performance (e.g., accuracy thresholds for ABI, Doppler velocity measurements) and no reported device performance data against such criteria. The submission states that "the devices meet all of their functional specifications," but these specifications are not detailed or quantified in terms of diagnostic output validity or reliability.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not provided. The submission does not describe any specific clinical test set, its size, or its provenance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not provided. Since no specific test set or clinical study demonstrating diagnostic performance is described, there's no mention of experts establishing ground truth. The document mentions that it is the "total responsibility of the system operator and the medical staff to modify the cursor location according to their medical training" for segmental blood pressure and other parameters, indicating the device relies on expert interpretation during use.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not provided. No specific test set for diagnostic performance is detailed in this submission.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable/Not provided. The device described is a non-invasive peripheral vascular diagnostic system, not an AI-assisted diagnostic tool for human readers in the typical sense of imaging review. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device's description. The submission focuses on substantial equivalence based on device features and general function to predicate devices, not on a human-AI interaction study.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable/Not provided. The Falcon devices are diagnostic instruments that capture physiological signals (pressure, PPG, Doppler) and perform calculations based on these signals. While the software automatically places cursors for certain measurements, the submission explicitly states that "it is the total responsibility of the system operator and the medical staff to modify the cursor location according to their medical training." This indicates intended human-in-the-loop operation, and no mention of a standalone algorithm-only performance study is made.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not provided. No specific ground truth methodology is described in relation to a study proving diagnostic accuracy. The device produces quantitative measurements (segmental systolic blood pressures, ABI, Doppler parameters, VRT, MVO/SVC ratio) that are then interpreted by medical staff. The document focuses on the correct functioning and calculation capabilities of the device itself, not on its diagnostic accuracy against a clinical gold standard.
The sample size for the training set:
- Not applicable/Not provided. The device does not appear to be an AI/machine learning device that requires a "training set" in the conventional sense. It's a measurement and calculation device for physiological signals.
How the ground truth for the training set was established:
- Not applicable/Not provided. As above, there is no mention of a training set or its associated ground truth establishment.

Summary of the Document's Focus:

This 510(k) submission primarily emphasizes:

Device Description: Detailing the hardware and software components and functionality of the Falcon/Pro, Falcon/Quad, and Falcon/ABI+ systems.
Substantial Equivalence: Comparing the new devices to legally marketed predicate devices (Vasoguard and Multilab Series II) based on features, intended use, performance capabilities (e.g., number of pressure channels, PPG sensors, Doppler frequencies, specialty tests), and compliance with general safety and performance standards.
Safety and Standards Compliance: Stating that the devices meet various electrical and medical device standards (EN, IEC, ISO).
User Responsibility: Highlighting that medical staff are ultimately responsible for interpreting the data and adjusting cursors for measurements.

The submission does not include data from clinical trials or performance studies that would typically provide specific acceptance criteria and detailed quantitative diagnostic performance metrics (e.g., sensitivity, specificity, accuracy) against a defined ground truth for conditions like peripheral vascular pathology. The approval is based on demonstrating substantial equivalence to existing devices already on the market rather than on new clinical performance data.

Summary

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510k SUBMISSION

Falcon/Pro, Falcon/Quad, Falcon/ABI+

K111416

JUL 1 5 2011

SUMMARY

This summary of 510k safety and effectiveness information is being submitted in accordance with 21CFR part 807.92

Submitters name, address, phone number, contact person and preparation 1. date:

Viasonix Ltd Name: 6B, Greenberg St. Rannana , ISRAEL Tel: 011 972 9 7441692

Responsible Person: Dan Manor

Official Correspondent:

William Stern Multigon Industries, Inc. 1 Odell Plaza Yonkers, N.Y. 10701 Phone: 914 376 5200 X27 Fax: 914 376 6111

Date of Preparation: May 17 , 2011

2. Device:

Proprietary Name: Falcon/Pro, Falcon/Quad, Falcon/ABI+

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Common Name: Transducer, Ultrasonic Classification Name: 21 CFR 870.2880 Regulation Number: Classification Number: 90JOP

Manufactured By: Viasonix Ltd 6B, Greenberg St. Rannana . ISRAEL Tel: 011 972 9 7441692

3. Substantial Equivalency

Device Description:

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the Falcon/Pro is 10. while the maximal allowed group for the sub-assemblies is 9: and the Falcon/ABI+ does not support any of the Doppler options and features.

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Device Components:

The main connectors on the front and right panels of the Falcon/Pro device are displayed in the picture below. These include the following:

Power switch, that is lit in green when turned on (on the front panel). -
-5 PPG connectors, color coded in red, green, blue, yellow and black (on the front panel).
3 Doppler probe connectors, with frequencies of 4, 8, and 10 MHz (on the front panel).
A connector for 1 external skin temperature sensor (on the side panel). -
-A connector for color coded 10 air tubes: red, blue, yellow, green, orange, red line, blue line, yellow line, green line and orange line (on the side panel).

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Image /page/4/Figure/0 description: The image shows a device with multiple labeled components. The front panel features a power switch, five PPG sensors, and three Doppler probes. On the side of the device, there is a temperature sensor and a 10-tube connector.

The front panel of the Falcon/Quad is similar to the front panel of the Falcon/Pro. except that instead of 5 PPG sensor connectors it has only 4 PPG connectors (red, blue, green and yellow). Otherwise, the 3 Doppler probes and the power switch are identical. The side panel connectors are also identical to those included in the Falcon/Pro, except that only 4 color coded air tubes are connected (red, blue, green and yellow).

The front panel of the Falcon/AB1+ is similar to the front panel of the Falcon/Quad, i.e. it has only 4 PPG connectors (red, blue, green and yellow). An additional change is that it does not have any Doppler probe connectors. The power switch is identical to the Falcon/Pro and Falcon/Quad. The side panel connectors are similar to the Falcon/Quad, i.e. a temperature sensor and only 4 color coded air tubes are connected to the tube connector (red, blue, green and yellow).

The back panel for all Falcon devices is identical. It includes 2 connectors, one is the power inlet from the power supply, and the second is a USB connector to connect the Falcon to the host computer via a USB cable.

Image /page/4/Figure/4 description: The image shows the back of an electronic device with labels pointing to the power inlet and USB connector. The power inlet is on the left side of the device, and the USB connector is located to the right of the power inlet. The back of the device also has a grid of small holes, possibly for ventilation. There is also a label with some text on the right side of the device.

The Falcon devices connect to an approved 12 V medical power supply, which in turn connect to the mains power. All other supportive device components connect directly to the host computer. These include: multi-key wired remote control, 3-pedal foot switch, key-board, mouse, printer, and USB camera. Additionally, a 2-sided medical grade adhesive sticker is available to securely connect the disk PPG sensor or the temperature sensor to the skin at the site of measurement.

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The remote control connects to the host computer via a USB connector. The remote control is designed for management of the most important Falcon functions and features that are used during an examination. In addition, it allows the user to operate away from the system, and by the patient bed. The remote control includes dedicated keys for most of the main functions, as well as some user defined keys. In general, there are four groups of keys in the remote control, as shown below: Signal Control Keys (with +/options), Main Keys, Arrows, and Configurable Keys (F1-F3).

Image /page/5/Picture/1 description: The image shows a remote control with several buttons. The buttons are labeled with various functions, including GAIN, SCALE, SWEEP, VOLUME, TARGET, DEF RATE, NEXT, FREEZE/REDO, RE-INFLATE, SUMMARY, and PRINT. There are also directional buttons and function keys labeled F1, F2, and F3, and the brand name VIASONIX is printed on the remote.

Predicate Device Comparison:

Feature	Vasoguard(Nicolet,Carefusion)	MultilabSeries II(Unetixs)	Falcon/Pro	Falcon/Quad	Falcon/ABI+
510(k) number	K002766	K904392	thisapplication	thisapplication	thisapplication
Indicationsfor use	noninvasiveevaluationofperipheralvascularpathology inpatients	noninvasiveevaluationofperipheralvascularpathology inpatients	noninvasiveevaluationofperipheralvascularpathology inpatients	noninvasiveevaluationof peripheralvascularpathology inpatients	noninvasiveevaluation ofperipheralvascularpathology inpatients
Pressurechannels	10	10	10	4	4
SimultaneousPVRmeasurements	10	2	10	4	4
PPG sensors	4	2	5	4	4
Dopplerprobes	4 and 8MHz CW	5 and 8MHz CW	4, 8 and 10MHz CW	4, 8 and 10MHz CW	N/A
Temperaturemeasurement	no	yes	yes	yes	yes
Specialty	stress	stress	stress	stress	stress

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tests	MVO/SVC, venousreflux, TOS	venousreflux, TOS	MVO/SVC, venousreflux, TOS	MVO/SVC, venousreflux, TOS	MVO/SVC, venousreflux, TOS		rise time	Venous refill time	Venous refill time	Venous refill time	Venous refill time	Venous refill time
Remotecontroloperation	yes, wired	yes,wireless	yes, wired	yes, wired	yes, wired	Calculatedvenous refluxtestparameters	MVO/SVCratio	N/A	MVO/SVCratio	MVO/SVCratio	MVO/SVCratio
Touch screencontrols	no	yes	yes	yes	yes		CalculatedMVO/SVCtestparameters	NicVue	floppy disk	DVD, USBstorage device	DVD, USBstorage device	DVD, USBstorage device
Foot switchcontrols	no	not known	yes	yes	yes			Backupoptions	available	available	available	available
Mouse andkeyboardcontrols	yes	yes	yes	yes	yes	Dicomconnectivity			Mostcommercialprintersavailable	Mostcommercialprintersavailable	Mostcommercialprintersavailable	Mostcommercialprintersavailable
Control oftargetinflationpressures	yes	yes	yes	yes	yes	Printersupport		available	available	available	available	available
Control ofpressuresdeflation rate	no	yes	yes	yes	yes	Customizedexaminationprotocols		availablebasicoptions	availablebasicoptions	availablemultipleoptions	availablemultipleoptions	availablemultipleoptions
Acoustictesting	track 1	not known	track 1	track 1	N/A	Configurationof printedreports	full, withpatienthistory	basic	full, withpatienthistory	full, withpatienthistory	full, withpatienthistory
Dopplerspectralanalysis	yes, 128point FFT	no	yes, 256point FFT	yes, 256point FFT	N/A	Patient details	not known	By name,ID numberand date	By name,ID number,date, andotherexaminationdetails	By name, IDnumber,date, andotherexaminationdetails	By name, IDnumber,date, andotherexaminationdetails
BidirectionalDoppler,invertfunction	yes	yes	yes	yes	N/A	Databasesearchoptions	no	not known	available	available	available
Dopplervolumecontrols	yes	yes	yes	yes	N/A	Online help	B	not known	B	B	B
Dopplerenvelope	upper,lower, both,none	N/A	upper,lower, both,none	upper,lower, both,none	N/A	EMC Class
Calculatedbloodpressureparameters	ABI,segmentalpressureindices	ABI,segmentalpressureindices	ABI,segmentalpressureindices	ABI,segmentalpressureindices	ABI,segmentalpressureindices
CalculatedDopplerparameters	Peakvelocity,meanvelocity,diastolicvelocity, PI,RI, systolic	none	Peakvelocity,meanvelocity,diastolicvelocity, PI,RI, S/D, HR	Peakvelocity,meanvelocity,diastolicvelocity, PI,RI, S/D, HR	N/A

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4. Performance Standards:

No performance standards have been established for the Falcon/Quad, Falcon/Quad, Falcon/ABI+ under section 514 of the Federal Food and Drug Act. However the Falcon/Pro, Falcon/Quad, Falcon/ABI+ have been designed to meet the following main standards:

EN 60601-1, Medical electrical equipment - Part 1. General requirements for safety (1990)

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IEC 60601-1-2. Medical electrical equipment - Part 1-2: Collateral Standard: Electromagnetic compatibility (2007).
IEC 60601-2-37, Medical electrical equipment -- Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment (2007-08).
IEC 62304, Medical device software -- Software life cycle processes (2006-05).
ISO 14971, Medical devices - Application of risk

management to medical devices (2007-10-01).

5. Indications for Use:

The Falcon/Pro, Falcon/Quad, and Falcon/ABI+ are intended for use in the noninvasive evaluation of peripheral vascular pathology in patients.

They are to be used by trained medical personnel in hospitals, clinics and physicians offices by prescription or doctor's orders.

6. Contra-Indications

None known at this time.

7. Comparison to predicate devices

The Falcon/Pro, Falcon/Quad, and Falcon/ABI+ products share similar device characteristics, intended use, performance, specifications and sensors, as other approved systems in the standard non-invasive diagnosis of peripheral vascular disease. The comparison table above details several of the key performance items with respect to the predicate devices Vasoguard (Nicolet, Carefusion) and Multilab II (Unetixs) systems that are commercially sold in the US and internationally.

In general, the Falcon product family (Falcon/Pro, Falcon/Quad, and Falcon/ABI+) and the predicate devices share common looks: a system casing, with variable connections to PPG sensors. Doppler probes (excluding Falcon/ABI+), and air tubes that connect to pressure cuffs. The Falcon products and the Vasoguard share the same 10-tube connector on the right side of the systems, that allows to easily disconnect all of the air tubes from the system. Display is via an external screen, and program controls in all systems can be carried out via key-board and mouse and remote controls, and in some systems additionally with touch screen and foot switch. In

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addition, all of the systems (Falcon and predicate devices) use color coding to identify the different sensors and air tubes that lead to the pressure cuffs.

The Falcon products and the predicate devices are designed for use by experienced medical staff. in medical environments such as hospitals, clinics and physicians' offices. They share similar intended use, and a similar range of performance and specialty test options, including: segmental blood pressure measurements, segmental PVR (pulse volume recording) tests, PPG (photoplethysmograph) tests. Doppler blood flow measurements, stress testing (measurement of the above tests following stress activity by the patient), venous reflux testing, impotence testing, MVO/SVC tests (maximal venous outflow / segmental venous capacitance), TOS tests (thoracic outlet syndrome), and other similar evaluations.

The Falcon products and the predicate devices are designed to provide both qualitative and quantitative information. The qualitative information mainly includes visual display of waveform shapes. including qualitative analysis of the PVR, PPG and Doppler waveforms. The quantitative information is focused primarily on aiding the examiners in obtaining systolic segmental blood pressures, and the corresponding segmental pressure indices including the ABI (ankle-brachial index). Additional quantitative measurements relate to the Doppler blood flow velocities and pulsatility indices, VRT (venous refill time) during venous reflux testing, and MVO/SVC ratio in the corresponding test.

The Falcon products and the predicate devices share similar signal and waveform controls, which directly affect both the signal and/or only the signal display. These controls include sweep time (controls the time axis display), scale (controls the Y axis display), gain (signal amplification), volume (Doppler audio sound level), target pressure level of initial cuff inflation), deflation rate (rate of cuff bleeding pressure (not for Vasuguard)), and signal filters (low pass and high pass).

In addition, the Falcon products and the predicate devices share similar standard features and options that are expected from such devices. These include: connection to external printers and report printing, management of patient database, offline review, routine backup of patient examinations, Dicom connectivity, summary examination screens, and configuration of examinations.

8. Test Data

The Falcon/Pro, Falcon/Quad, and Falcon/ABI+ range of non-invasive peripheral vascular diagnostic systems have been subjected to extensive safety, performance testing, and validation before release. Final testing of the Falcon/Pro, Falcon/Quad, and Falcon/ABI+ range of noninvasive peripheral vascular diagnostic systems included various performance testing that are designed to ensure that the devices meet all of their functional specifications. Safety and EMC tests have been performed by an approved laboratory to ensure that the devices comply with applicable industry and safety standards.

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The Falcon/Pro, Falcon/Quad, and Falcon/ABI+ range of non-invasive peripheral vascular diagnostic systems labeling includes instructions for safe and effective use, warnings, cautions and guidance for use. In addition, all of the warnings, cautions, and instructions for use are provided by the program for immediate online review by the user. It is therefore shown to be safe and effective.

9. Literature Review

A review of the literature pertaining to the safety of the Falcon/Pro, Falcon/Quad, and Falcon/ABI+ range of non-invasive peripheral vascular diagnostic systems has been conducted and appropriate safeguards have been incorporated in the design of the Falcon/Pro, Falcon/Quad, and Falcon/ABI+ range of non-invasive peripheral vascular diagnostic systems.

10. Conclusions

The conclusion drawn from these tests is that the Falcon/Pro, Falcon/Quad, and Falcon/ABI+ range of non-invasive peripheral vascular diagnostic systems are equivalent in safety and efficacy to the predicate devices listed in the comparison table above.

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Image /page/11/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized eagle or bird in flight, with three human profiles incorporated into its design.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Viasonix, Ltd. % Mr. William Stern Official Correspondent Multigon Industries, Inc. 1 Odell Plaza YONKERS NY 10701

JUL 15 2011

Re: K111416

Trade/Device Name: Falcon/Pro, Falcon/Quad, and Falcon/ABI+ Regulation Number: 21 CFR 870.2880 Regulation Name: Ultrasonic transducer Regulatory Class: II Product Code: JOP Dated: May 17, 2011 Received: May 20, 2011

Dear Mr. Stern:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

This determination of substantial equivalence applies to the following transducers intended for use with the Falcon/Pro, Falcon/Quad, and Falcon/ABI+, as described in your premarket notification:

Transducer Model Number

4MHz CW 8MHz CW 10MHz

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If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR.Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

If you have any questions regarding the content of this letter, please contact Lauren Hefner at (301) 796-6542.

Sincerely Yours,

Mary S Potter

Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure(s)

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Indications for Use

510(k) Number (if known): K111416

Device Name: ____ Falcon/Pro, Falcon/Quad, and Falcon/ABI+

Indications for Use:

The Falcon/Pro, Falcon/Quad, and Falcon/ABI+ are intended for use in the noninvasive evaluation of peripheral vascular pathology in patients.

They are to be used by trained medical personnel in hospitals, clinics and physicians offices by prescription or doctor's orders.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Mary S. Postel

Division Sign-Off Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) Number K111416

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Contains Nonbinding Recommendations Appendix G

Appendix G: Example Diagnostic Ultrasound Indications For Use Format

The Falcon/Pro, Falcon/Quad

Transducer: すことができることです。
ここではなくなっています。こんなので、ここでは、ここでは、ここでは、ここで、ここで、ここで、ここで、ここで、ここで、ここで、ここで、ここで、ここで、ここで、ここで、ここで、ここで、ここで、ここで、ここで、ここで、ここで、ここで、ここで、ここで、ここで、ここで、こ

System:

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other*(Specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
FetalImaging& Other	Pediatric
	Small Organ (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal							:
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)
	Musculo-skeletal(Superficial)
	Intravascular
	Other (Specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
PeripheralVessel	Peripheral vessel				N
Vessel	Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix

Examples of other modes of operation may include: A-mode, Amplitude Doppler, 3-D

Imaging, Harmonic Ingging Tissue Motion Doppler, and Color Velocity Imaging

(Division Sign-Off)
Division of Radiological Devices

Office of In Vitro Diagnostic Device Evaluation a

510K

{15}------------------------------------------------

Appendix G: Example Diagnostic Ultrasound Indications For Use Format

The Falcon/Pro, Falcon/Quad

Transducer: 8 MHZ CW

System:

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other*(Specify)
Ophthalmic	Ophthalmic
FetalImaging& Other	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)
	Musculo-skeletal(Superficial)
	Intravascular
	Other (Specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
PeripheralVessel	Peripheral vessel				N
	Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix * Examples of other modes of operation may include: A-mode, Amplitude Doppler, 3-D

Imaging, Harmonic Imaging, Tissue Motion Doppler, and Color Velocity Imaging,

Mury S. Patel
(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and S

SIOK

{16}------------------------------------------------

Appendix G: Example Diagnostic Ultrasound Indications For Use Format

The Falcon/Pro, Falcon/Quad

Transducer: 10_мнz

System:

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
General	Specific	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other*(Specify)
(Track 1 Only)	(Tracks 1 & 3)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify)
	Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal(Conventional)
Musculo-skeletal(Superficial)
Intravascular
Other (Specify)
FetalImaging& Other	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Other (Specify)
Cardiac	Other (Specify)
	Peripheral vessel				N
	PeripheralVessel	Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix

Examples of other modes of operation may include: A-mode, Amplitude Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler, and Color Velocity Imaging

Mary S. Postid
(Division Sign-Off)

Division of Radiological Der Office of in Vitro Diagnostic Dev

510K

Regulation Number and Section

§ 870.2880 Ultrasonic transducer.

(a)
Identification. An ultrasonic transducer is a device applied to the skin to transmit and receive ultrasonic energy that is used in conjunction with an echocardiograph to provide imaging of cardiovascular structures. This device includes phased arrays and two-dimensional scanning transducers.(b)
Classification. Class II (performance standards).